BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSTER SCREW SYSTEM

    MDR report key: 14466364 · Received May 21, 2022

    Report

    Report Number
    3008650117-2022-00058
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 20, 2022
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190586
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SCREW BROKE DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368295 MONSTER SCREW SYSTEM MONSTER BEAM, CANNULATED, HEADLESS, FULL THD, 7.2 X 140MM HWC PARAGON 28, INC. P26-572-140F

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male